Direct Pulp Capping with Calcium Hydroxide, Mineral Trioxide Aggregate, and Biodentine in Permanent Young Teeth with Caries: A Randomized Clinical Trial Claudia Brizuela, DDS, MS, PhD,* Andrea Orme ~ no, DDS, MS, PhD,* Carolina Cabrera, DDS,* Roxana Cabezas, DDS, MS,* Carolina Inostroza Silva, BS, MS, PhD,* Valeria Ram  ırez, DDS, MS,* and Montse Mercade, DDS, MS, PhD † Abstract Introduction: Direct pulp capping treatment is in- tended to preserve pulp vitality, to avoid or retard root canal treatment, and, in cases with an open apex, to allow continued root development. Historical- ly, calcium hydroxide (CH) was the gold standard ma- terial, but nowadays calcium silicate materials (CSMs) are displacing CH because of their high bioac- tivity, biocompatibility, sealing ability, and mechanical properties. However, more randomized clinical trials are needed to confirm the appropriateness of CSMs as replacement materials for CH in direct pulp capping procedures. Methods: A randomized clinical trial was conducted that included 169 patients (mean age, 11.3 years) from the Maipo district (Chile). The inclu- sion criterion was patients with 1 carious permanent tooth with pulpal exposure, a candidate for a direct pulp capping procedure. The patients were randomly allocated to one of the experimental groups (CH, Biodentine, or mineral trioxide aggregate [MTA]). Clin- ical follow-up examinations were performed at 1 week, 3 months, 6 months, and 1 year. The Fisher exact test was performed. Results: At the follow-up examination at 1 week, the patients showed 100% clinical success. At 3 months, there was 1 failure in the CH group. At 6 months, there were 4 new failures (1 in the CH group and 3 in the MTA group). At 1 year, there was another failure in the CH group. There were no statistically sig- nificant differences among the experimental groups. Conclusions: CSMs appear to be suitable materials to replace CH. Although no significant differences were found among the materials studied, Biodentine and MTA offered some advantages over CH. (J Endod 2017;-:1–5) Key Words Biodentine, calcium hydroxide, direct pulp capping, mineral trioxide aggregate, randomized clinical trial T reatment of pulpal exposure in permanent teeth is a challenge for cli- nicians. Traumatic injuries, anatomic anomalies, and extensive caries can cause inflammation of the pulp and arrested root development. Different strategies have been used for vital pulp therapy; these are indirect or direct pulp capping and pulpotomy. The main goal of vital pulp ther- apy is to preserve pulpal tissue, remove tissue that is contaminated by bacteria, and pro- mote repair of the mineralized tissue barrier (dentin bridge). Direct pulp capping is a procedure wherein a small exposure of pulp is covered with a protective wound dressing (1). This treatment is intended to avoid future root canal treatment or at least postpone it until root formation is complete (2). Numerous materials have been used throughout the years for pulp capping. Calcium hydroxide (CH) has been the gold standard in recent decades (3–5); however, calcium silicate materials (CSMs) have been used in more and more clinical applications since their development. Calcium hydroxide has some obvious drawbacks, including inflammation and necrosis of the pulp surface after pulp capping, high solubility in oral fluids, degradation over time, the formation of tunnel defects inside the dentin bridge, and low mechanical resistance, which might cause future microfiltration and failure of the treatment (6–9). Mineral trioxide aggregate (MTA) was the first CSM to be marketed. Since its approval by the Food and Drug Administration in 1998, it has been used with increasing frequency, with very good clinical and in vitro results (10–12). In a systematic review with a meta-analysis that compared the effectiveness of MTA and CH as pulp capping materials in permanent human teeth, the conclusion was that MTA has a higher success rate and results in less pulpal inflammation and more predictable formation of a hard dentin bridge than CH (13). This conclusion demonstrates that MTA is a suitable ma- terial for direct pulp capping procedures and argues against the continuing recommen- dation of CH as the gold standard for such treatments. However, as the first CSM, MTA From the *Dental School, Universidad de Los Andes, Santiago, Chile; and † Dental School, Universitat de Barcelona, Barcelona, Spain. Address requests for reprints to Dr Claudia Brizuela, Universidad de los Andes, Facultad de Odontolog  ıa, Av. Monse~ nor  Alvaro del Portillo 12.455, Las Condes, Santiago, Chile. E-mail address: clau@cibrizuela.com 0099-2399/$ - see front matter Copyright ª 2017 American Association of Endodontists. http://dx.doi.org/10.1016/j.joen.2017.06.031 Significance This is the first clinical trial to compare the efficacy of the most frequently used and reported material for direct pulp capping in permanent teeth (CH) versus the new CSMs (MTA and Biodentine). CONSORT Randomized Clinical Trial JOE — Volume -, Number -, - 2017 Direct Pulp Capping in Carious Permanent Teeth 1